Unseen Regulatory and Intellectual Property Impact of Genus
Regulatory history was made on 9 August 2021 in a Federal Register notice (Docket No: FDA-2021-N-0843) announcing that in accordance with the Genus decision, FDA intends to regulate products that meet both drug and device definition as medical devices, except where the statute indicates that Congress intended a different classification.
What’s more, FDA also plans to review all FDA-approved imaging agents and potentially reclassify them as drugs or devices according to whether they achieve their primary intended purpose through chemical action or are dependent on being metabolized for the achievement of their primary intended purpose. This means that some currently approved imaging agents regulated as drugs will transition to be regulated as medical devices!
Dr. Lisa VanLuvanee is the Chief Operating Officer and Vice President of Research and Development at Facet Life Sciences (formerly Virtual Regulatory Solutions, Inc.), a company devoted to helping small organizations progress their products to and through FDA. Dr. VanLuvanee has over 20 years of experience in the life sciences industry. Her expertise includes portfolio and product development strategies, regulatory submission strategies, clinical endpoint selection, dossier preparation and submission, and post-approval life-cycle management. She has worked on a variety of drug, biological, medical device, and combination products for cardiovascular, CNS (neurology and psychiatry), dermatology, GI, inflammation, infectious disease, ophthalmology, pulmonary, oncology, pain, urology (reproductive), and women’s health indications in both the pre- and post-approval space. Dr. VanLuvanee has also been involved in the development and approval of diagnostic and therapeutic radiopharmaceuticals since 2003. She leads the Facet clinical, CMC, and nonclinical regulatory team of experts who provide US regulatory affairs strategic and tactical support for drug, biologic, cellular, protein, and gene therapy, vaccine, medical device, and combination products for a variety of indications. Facet is a recognized industry expert in the US regulatory development and registration of diagnostic and therapeutic imaging agents and presented at a co-sponsored (SNMMI and FDA) PET radiopharmaceuticals workshop on Inspections Management and Regulatory Considerations.
Jeremy A. Cubert is a Partner in the firm’s Intellectual Property Practice. With over 22 years of experience in patent law with an emphasis in life sciences, Mr. Cubert assists companies in all aspects of obtaining and managing their intellectual property portfolios. He has extensive experience in patent prosecution, due diligence and analysis of intellectual property portfolios and counsels clients regarding the acquisition and licensing of intellectual property assets. Mr. Cubert regularly works directly with scientists and professionals at academic institutions, biotechnology companies, and Fortune 500 companies to develop intellectual property development and management plans.
Dr. Jur Strobos has spent more than 30 years providing legal, regulatory, strategic development, management, and policy advice to life science companies that manufacture, import, or sell medical products (drugs, devices, biologics, cell and gene therapy, human tissues), foods, cosmetics, tobacco regulated by the US Food and Drug Administration (FDA) or comparable international authorities. Dr. Strobos is a medical doctor and a credentialed federal law enforcement officer. He previously served as a legal, regulatory, and policy official in the Commissioner’s Office at FDA.